Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.

Due to a software issue

On 10/22/2025 a "Customer Advisory Notification" via email to customers informing them of a software update to deal with potential of aborted test runs due to Error Code 0x25000012 (Pressure wet filter error). Customer were informed that an over-the-air software update will automatically be available when the DASH Instrument is connected to the internet. For questions or assistance - Nuclein Customer Support at 1-888-992-DASH (3274) or [email protected] On 07/30/2026, an updated "URGENT: MEDICAL DEVICE CORRECTION" Letter was email to customers. The updated letter informed customer of the potential issues associated with the software issue that was not addressed in the initial letter sent on 10/22/2025.